Search Results: Legislation Tracker

Update: Obamacare and TPP

While Donald Trump’s victory has made world headlines, what may be less well known to our readers is that the election also gave Trump’s Republican Party majority control of both the House and the Senate.  For the first time in many years, Republicans will control both the White House and…

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TPP Updates: McConnell, No Congressional Approval This Year

Majority Leader Mitch McConnell said that the Senate will not vote on the TPP agreement this year, seemingly foreclosing the possibility of passage during President Obama’s tenure. Administration officials continue to push for the deal and hold out hope as Treasury Secretary Jack Lew noted in comments at the Brookings Institute. Meanwhile,…

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Missouri Governor Signs Biosimilar Substitution Law

Last month, Missouri Governor Jay Nixon signed into law Senate Bill 875, allowing pharmacists filling prescriptions for brand name biological products to substitute a less expensive biosimilar product if the biosimilar has been approved by the FDA to be an interchangeable biological product. Missouri is now the twenty second state…

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Legislation Tracker: PRICED Act Proposes to Shorten Biologic Exclusivity Period from 12 to 7 Years

A bill introduced in the House of Representatives yesterday proposes “[t]o amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 7 years.” Titled the “Price Relief, Innovation, and Competition for Essential Drugs Act,” or the “PRICED Act,” the proposed bill…

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TPP Updates: Japan and Canada Begin Deliberations on Trade Deal Ratification

Since the TPP’s signing by twelve Pacific Rim countries this past February, the agreement has been making its way through the “next phase” of its development—ratification through the signatory countries’ “respective domestic processes.”   As we’ve covered previously (see our posts here and here), if enacted, the TPP’s intellectual property provisions…

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House Subcommittee on Health Addresses BPCIA Implementation and FDA Biosimilars Guidance

The House Energy & Commerce Committee’s Subcommittee on Health met this morning to discuss implementation of the Biologics Price Competition and Innovation Act. Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare, and Janet Woodcock, Director of the Center for Drug Evaluation and Research, testified. The subcommittee’s questioning…

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